Most recent PRV is a reminder of why Congress should reform the US government program to only reward companies for developing new and affordable drugs and vaccines for neglected diseases
NEW YORK, FEBRUARY 20, 2019—The U.S. Food and Drug Administration (FDA) recently awarded pharmaceutical corporation Novartis its second Priority Review Voucher (PRV) for an old neglected disease drug, once again highlighting the fact the program is failing the people it is supposed to help: those living with some of the world’s more neglected diseases, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF). While the PRV is meant to promote the creation of new and better medical products for people living with neglected diseases, it is ripe for abuse. Time after time, PRVs have been awarded for a treatment or vaccine that is either not new, not accessible or affordable, or both.
Under the neglected disease PRV program, when the FDA approves an eligible neglected disease product—a medicine or vaccine—a company is awarded a PRV. This voucher can then be used to accelerate the FDA review of any of the company’s drugs or vaccines. Alternatively, the company can choose to sell their voucher to another company, as has been done for as much as $350 million.
If the incentive worked properly, developers would be rewarded for making available new and improved neglected disease products, and people affected by neglected diseases would benefit from urgently-needed new treatments and vaccines. However, companies have been rewarded with PRVs for simply registering an existing medicine in the US; products do not have to be new for patients, and the company does not have to make the treatment or vaccine accessible and affordable for people in need.
In this most recent case, Novartis received a PRV for an old treatment called triclabendazole, which has been used to treat people with fascioliasis (also called liver fluke) since 1989 and was registered by 1998—almost a decade before the PRV program even existed. Additionally, the drug was placed on the WHO Essential Medicines List by 2002. Even in the US, the CDC has called triclabendazole the “drug of choice” for fascioliasis treatment since at least 2013. This is the second time Novartis has gotten a PRV for an old medicine as they received a PRV in 2009—the first one ever awarded for neglected diseases—for a malaria treatment (artemether/lumefantrine) that was first registered in 1998.
For years, MSF and others have been calling on Congress to fix these loopholes so the program works as it was intended to work and helps people in need of new medicines and treatments. While Congress has made changes and additions to the program, they have failed to effectively protect the value of this lucrative incentive for urgently needed innovation. For example, Congress passed the FDA Reauthorization Act (FDARA) of 2017 which included a new amendment that said a company must conduct a clinical study on a product in order to get a PRV, but that doesn’t prevent old products from winning a PRV. Also worth noting in this case, the FDA stated the new amendments didn’t apply to the Novartis application because the company submitted the “first portion” of their NDA before they came into effect.
“Each and every day, Doctors Without Borders sees unmet medical needs in the field that could be addressed if the creation of affordable new medicines and vaccines for some of the world’s most neglected diseases was properly incentivized.
“The PRV program is supposed to make sure people with neglected diseases aren’t left out in the cold, but, instead, has been misused by pharmaceutical corporations time after time to rake in millions of dollars without truly delivering new and affordable treatments that actually benefit those with neglected diseases.
“Awarding Novartis yet another PRV for a drug that has been widely used all over the world for years further undermines the program as an incentive for companies to invest in creating truly needed products.
“Lawmakers need to stand up to pharma and fix the PRV program once and for all so companies stop gaming the system and only get PRVs when they introduce new and affordable medicines and vaccines people all over the world desperately need.”
—Jennifer Reid, policy analyst for MSF’s Access Campaign